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RU2020142965A - IMMUNOGLOBULIN WITH TANDEM LOCATION OF FAB-FRAGMENTS AND ITS APPLICATION - Google Patents

IMMUNOGLOBULIN WITH TANDEM LOCATION OF FAB-FRAGMENTS AND ITS APPLICATION Download PDF

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RU2020142965A
RU2020142965A RU2020142965A RU2020142965A RU2020142965A RU 2020142965 A RU2020142965 A RU 2020142965A RU 2020142965 A RU2020142965 A RU 2020142965A RU 2020142965 A RU2020142965 A RU 2020142965A RU 2020142965 A RU2020142965 A RU 2020142965A
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binding protein
disease
binding
cancer
seq
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RU2020142965A
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Russian (ru)
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RU2769133C2 (en
RU2020142965A3 (en
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Чэнбинь У
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Эпимаб Биотерапьютикс Инк.
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Claims (43)

1. Связывающий белок, содержащий три полипептидные цепи, причем: 1. A binding protein containing three polypeptide chains, and: первая полипептидная цепь содержит, от амино-конца к карбоксильному концу, либо (i) VLA-CL-VHB-CH1-Fc, где CL слит непосредственно с VHB, либо (ii) VHB-CH1-VLA-CL-Fc, где CH1 слит непосредственно с VLA, и при этом между вариабельными доменами и константными доменами нет встроенных линкеров; the first polypeptide chain comprises, from the amino terminus to the carboxyl terminus, either (i) VL A -CL-VH B -CH1-Fc, where CL is fused directly to VH B , or (ii) VH B -CH1-VL A -CL -Fc, where CH1 is fused directly with VL A , and there are no inserted linkers between the variable domains and the constant domains; при этом вторая полипептидная цепь содержит, от амино-конца к карбоксильному концу, VHA-CH1, при этом между VHA и CH1 нет встроенных линкеров;wherein the second polypeptide chain contains, from the amino end to the carboxyl end, VH A —CH1, and there are no inserted linkers between VH A and CH1; при этом третья полипептидная цепь содержит, от амино-конца к карбоксильному концу, VLB-CL, при этом между VLB и CL нет встроенных линкеров;wherein the third polypeptide chain contains, from the amino end to the carboxyl end, VL B -CL, and there are no inserted linkers between VL B and CL; при этом A представляет собой первый эпитоп или антиген, и B представляет собой второй эпитоп или антиген, и при этом A и B являются разными эпитопами одного антигена или разными антигенами;wherein A is the first epitope or antigen, and B is the second epitope or antigen, and wherein A and B are different epitopes of the same antigen or different antigens; причем VLA представляет собой вариабельный домен легкой цепи первого родительского антитела, которое связывается с A, CL представляет собой константный домен легкой цепи антитела, VHB представляет собой вариабельный домен тяжелой цепи второго родительского антитела, которое связывается с B, CH1 представляет сбой первый константный домен тяжелой цепи антитела, VHA представляет собой вариабельный домен тяжелой цепи указанного первого родительского антитела, которое связывается с A, и VLB представляет собой вариабельный домен легкой цепи указанного второго родительского антитела, которое связывается с B; иwherein VL A is the variable domain of the light chain of the first parental antibody that binds to A, CL is the constant domain of the light chain of the antibody, VH B is the variable domain of the heavy chain of the second parental antibody that binds to B, CH1 is the malfunction of the first constant domain the heavy chain of the antibody, VH A is the variable domain of the heavy chain of said first parental antibody that binds to A, and VL B is the variable domain of the light chain of the specified second parental antibody that binds to B; and при этом две из указанных первых полипептидных цепей, две из указанных вторых полипептидных цепей и две из указанных третьих полипептидных цепей способны ассоциировать с образованием тетравалентного связывающего белка с двойной специфичностью, содержащего шесть полипептидных цепей, содержащих четыре функциональных связывающих участка Fab, и при этом указанный связывающий белок связывает как эпитоп или антиген A, так и эпитоп или антиген B.wherein two of said first polypeptide chains, two of said second polypeptide chains and two of said third polypeptide chains are capable of associating with the formation of a tetravalent binding protein with double specificity, containing six polypeptide chains containing four functional Fab binding sites, and wherein said binding the protein binds both an A epitope or antigen and a B epitope or antigen. 2. Связывающий белок по п. 1, отличающийся тем, что Fc представляет собой Fc IgG1 человека.2. The binding protein of claim 1, wherein the Fc is human IgG1 Fc. 3. Связывающий белок по п. 1, отличающийся тем, что Fc соответствует SEQ ID NO: 20.3. The binding protein of claim 1, wherein the Fc corresponds to SEQ ID NO: 20. 4. Связывающий белок по п. 1, отличающийся тем, что Fc представляет собой вариант Fc.4. The binding protein of claim 1, wherein the Fc is an Fc variant. 5. Связывающий белок по любому из пп. 1-4, отличающийся тем, что указанный связывающий белок способен к связыванию пар цитокинов, выбранных из группы, состоящей из ИЛ-1α и ИЛ-1β; ИЛ-12 и ИЛ-18; TNFα и ИЛ-23; TNFα и ИЛ-13; ФНО и ИЛ-18; ФНО и ИЛ-12; ФНО и ИЛ-1-бета; ФНО и MIF; ФНО и ИЛ-6; ФНО и рецептора ИЛ-6; ФНО и ИЛ-17; ИЛ-17 и ИЛ-20; ИЛ-17 и ИЛ-23; ФНО и ИЛ-15; ФНО и VEGF; VEGFR и EGFR; ИЛ-13 и ИЛ-9; ИЛ-13 и ИЛ-4; ИЛ-13 и ИЛ-5; ИЛ-13 и ИЛ-25; ИЛ-13 и TARC; ИЛ-13 и MDC; ИЛ-13 и MIF; ИЛ-13 и TGF-β; ИЛ-13 и агонист LHR; ИЛ-13 и CL25; ИЛ-13 и SPRR2a; ИЛ-13 и SPRR2b; ИЛ-13 и ADAM8; и TNFα и PGE4; ИЛ-13 и PED2; ФНО и PEG2.5. Binding protein according to any one of claims. 1-4, characterized in that said binding protein is capable of binding pairs of cytokines selected from the group consisting of IL-1α and IL-1β; IL-12 and IL-18; TNFα and IL-23; TNFα and IL-13; FNO and IL-18; FLO and IL-12; TNF and IL-1-beta; TNF and MIF; TNF and IL-6; TNF and IL-6 receptor; FLO and IL-17; IL-17 and IL-20; IL-17 and IL-23; FNO and IL-15; TNF and VEGF; VEGFR and EGFR; IL-13 and IL-9; IL-13 and IL-4; IL-13 and IL-5; IL-13 and IL-25; IL-13 and TARC; IL-13 and MDC; IL-13 and MIF; IL-13 and TGF-β; IL-13 and LHR agonist; IL-13 and CL25; IL-13 and SPRR2a; IL-13 and SPRR2b; IL-13 and ADAM8; and TNFα and PGE4; IL-13 and PED2; TNF and PEG2. 6. Связывающий белок по п. 5, отличающийся тем, что указанный связывающий белок связывает ИЛ-17 человека и ИЛ-20 человека.6. The binding protein of claim 5, wherein said binding protein binds human IL-17 and human IL-20. 7. Связывающий белок по п. 6, отличающийся тем, что указанный связывающий белок содержит вариабельные тяжелые и легкие цепи, полученные из антитела LY к ИЛ-17 и антитела 15D2 к ИЛ-20.7. The binding protein of claim 6, wherein said binding protein comprises variable heavy and light chains derived from anti-IL-17 LY antibody and anti-IL-20 antibody 15D2. 8. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок содержит первую полипептидную цепь, содержащую аминокислотную последовательность SEQ ID NO: 15; вторую полипептидную цепь, содержащую аминокислотную последовательность в соответствии с SEQ ID NO: 21; и третью полипептидную цепь, содержащую последовательность в соответствии с SEQ ID NO: 23.8. Binding protein according to claim 1, wherein said binding protein comprises a first polypeptide chain containing the amino acid sequence of SEQ ID NO: 15; a second polypeptide chain containing the amino acid sequence in accordance with SEQ ID NO: 21; and a third polypeptide chain comprising the sequence according to SEQ ID NO: 23. 9. Связывающий белок по любому из пп. 1-4, отличающийся тем, что указанный связывающий белок способен к связыванию пар мишеней, выбранных из группы, состоящей из CD138 и CD20; CD138 и CD40; CD19 и CD20; CD20 и CD3; CD3 и CD33; CD16 и CD33; CD3 и CD133; CD38 и CD138; CD38 и CD20; CD20 и CD22; CD38 и CD40; CD40 и CD20; CD-8 и ИЛ-6; CSPG и RGM A; CTLA-4 и BTNO2; IGF1 и IGF2; IGF1/2 и ErbB2; IGF-1R и EGFR; EGFR и CD13; IGF-1R и ErbB3; EGFR-2 и IGFR; VEGFR-2 и Met; VEGF-A и Ангиопоэтина-2 (Ang-2); ИЛ-12 и TWEAK; ИЛ-13 и ИЛ-1-бета; MAG и RGM A; NgR и RGM A; NogoA и RGM A; OMGp и RGM A; PD-L1 и CTLA-4; PD-1 и CTLA-4; PD-1 и TIM-3; CD137 и CD20; CD137 и EGFR; CD137 и Her-2; CD137 и PD-1; CD137 и PD-L1; VEGF и PD-L1; Lag-3 и TIM-3; OX40 и PD-1; TIM-3 и PD-L1; EGFR и DLL-4; PDGFR и VEGF; EpCAM и CD3; Her2 и CD3; CD19 и CD3; EGFR и Her3; CD16a и CD30; CD30 и PSMA; EGFR и CD3; CEA и CD3; TROP-2 и HSG; TROP-2 и CD3; VEGF и EGFR; HGF и VEGF; VEGF и VEGF (другим эпитопом); EGFR и cMet; PDGF и VEGF; VEGF и DLL-4; OX40 и PD-L1; ICOS и PD-1; ICOS и PD-L1; Lag-3 и PD-1; Lag-3 и PD-L1; Lag-3 и CTLA-4; ICOS и CTLA-4; CD47 и CD20; RGM A и RGM B; Te38 и TNFα; TNFα и Blys; TNFα и CD-22; TNFα и домен CTLA-4; TNFα и GP130; TNFα и ИЛ-12p40; и TNFa и лиганд RANK.9. Binding protein according to any one of paragraphs. 1-4, characterized in that said binding protein is capable of binding target pairs selected from the group consisting of CD138 and CD20; CD138 and CD40; CD19 and CD20; CD20 and CD3; CD3 and CD33; CD16 and CD33; CD3 and CD133; CD38 and CD138; CD38 and CD20; CD20 and CD22; CD38 and CD40; CD40 and CD20; CD-8 and IL-6; CSPG and RGM A; CTLA-4 and BTNO2; IGF1 and IGF2; IGF1 / 2 and ErbB2; IGF-1R and EGFR; EGFR and CD13; IGF-1R and ErbB3; EGFR-2 and IGFR; VEGFR-2 and Met; VEGF-A and Angiopoietin-2 (Ang-2); IL-12 and TWEAK; IL-13 and IL-1-beta; MAG and RGM A; NgR and RGM A; NogoA and RGM A; OMGp and RGM A; PD-L1 and CTLA-4; PD-1 and CTLA-4; PD-1 and TIM-3; CD137 and CD20; CD137 and EGFR; CD137 and Her-2; CD137 and PD-1; CD137 and PD-L1; VEGF and PD-L1; Lag-3 and TIM-3; OX40 and PD-1; TIM-3 and PD-L1; EGFR and DLL-4; PDGFR and VEGF; EpCAM and CD3; Her2 and CD3; CD19 and CD3; EGFR and Her3; CD16a and CD30; CD30 and PSMA; EGFR and CD3; CEA and CD3; TROP-2 and HSG; TROP-2 and CD3; VEGF and EGFR; HGF and VEGF; VEGF and VEGF (another epitope); EGFR and cMet; PDGF and VEGF; VEGF and DLL-4; OX40 and PD-L1; ICOS and PD-1; ICOS and PD-L1; Lag-3 and PD-1; Lag-3 and PD-L1; Lag-3 and CTLA-4; ICOS and CTLA-4; CD47 and CD20; RGM A and RGM B; Te38 and TNFα; TNFα and Blys; TNFα and CD-22; TNFα and CTLA-4 domain; TNFα and GP130; TNFα and IL-12p40; and TNFa and RANK ligand. 10. Связывающий белок по п. 9, отличающийся тем, что указанный связывающий белок способен к связыванию CD3 человека и CD20 человека.10. The binding protein of claim 9, wherein said binding protein is capable of binding human CD3 and human CD20. 11. Связывающий белок по п. 10, отличающийся тем, что указанный связывающий белок содержит вариабельные тяжелые и легкие цепи, полученные из антитела OKT3 к CD3 и антитела офатумумаб к CD20.11. The binding protein of claim 10, wherein said binding protein comprises variable heavy and light chains derived from anti-CD3 OKT3 antibody and anti-CD20 antibodies ofatumumab. 12. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок содержит первую полипептидную цепь, содержащую аминокислотную последовательность SEQ ID NO: 41; вторую полипептидную цепь, содержащую аминокислотную последовательность в соответствии с SEQ ID NO: 44; и третью полипептидную цепь, содержащую аминокислотную последовательность в соответствии с SEQ ID NO: 46.12. Binding protein according to claim 1, wherein said binding protein comprises a first polypeptide chain comprising the amino acid sequence of SEQ ID NO: 41; a second polypeptide chain containing the amino acid sequence in accordance with SEQ ID NO: 44; and a third polypeptide chain containing the amino acid sequence in accordance with SEQ ID NO: 46. 13. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок способен к связыванию одного или более эпитопов на CTLA-4.13. The binding protein of claim 1, wherein said binding protein is capable of binding one or more epitopes on CTLA-4. 14. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок способен к связыванию одного или более эпитопов на PD-1.14. The binding protein of claim 1, wherein said binding protein is capable of binding one or more epitopes on PD-1. 15. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок способен к связыванию одного или более эпитопов на белке, который представляет собой белок иммунных контрольных точек на T- клетках.15. The binding protein of claim 1, wherein said binding protein is capable of binding one or more epitopes on a protein that is an immune checkpoint protein on T cells. 16. Связывающий белок по п. 15, отличающийся тем, что белок иммунных контрольных точек выбран из группы, состоящей из TIM-3, Lag3, ICOS, BTLA, CD160, 2B4, KIR, CD137, CD27, OX40, CD40L и A2aR.16. The binding protein of claim 15, wherein the immune checkpoint protein is selected from the group consisting of TIM-3, Lag3, ICOS, BTLA, CD160, 2B4, KIR, CD137, CD27, OX40, CD40L and A2aR. 17. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок способен к связыванию одного или более эпитопов на белке, который вовлечен в реализацию функций иммунных контрольных точек.17. A binding protein according to claim 1, wherein said binding protein is capable of binding one or more epitopes on a protein that is involved in immune checkpoint functions. 18. Связывающий белок по п. 17, отличающийся тем, что указанный белок выбран из группы, состоящей из PD-L1, PD-L2, Галектина-9, HVEM, CD48, B7-1, B7-2, ICOSL, B7-H3, B7-H4, CD137L, OX40L, CD70 и CD40.18. The binding protein of claim 17, wherein said protein is selected from the group consisting of PD-L1, PD-L2, Galectin-9, HVEM, CD48, B7-1, B7-2, ICOSL, B7-H3 , B7-H4, CD137L, OX40L, CD70 and CD40. 19. Связывающий белок по любому из пп. 1-18, отличающийся тем, что указанный связывающий белок связывается с каждым антигеном с подобной или большей степенью аффинности по сравнению с моноспецифическим антителом или фрагментом антитела.19. Binding protein according to any one of paragraphs. 1-18, characterized in that said binding protein binds to each antigen with a similar or greater degree of affinity as compared to a monospecific antibody or antibody fragment. 20. Связывающий белок по любому из пп. 1-19, отличающийся тем, что указанный связывающий белок конъюгирован со средством, выбранным из группы, состоящей из молекулы иммуноадгезии, средства для визуализации, терапевтического средства и цитотоксического средства.20. Binding protein according to any one of paragraphs. 1-19, characterized in that said binding protein is conjugated to an agent selected from the group consisting of an immunoadhesion molecule, an imaging agent, a therapeutic agent, and a cytotoxic agent. 21. Фармацевтическая композиция, содержащая эффективное количество связывающего белка по любому из пп. 1-20 и один или более фармацевтически приемлемых носителей.21. A pharmaceutical composition containing an effective amount of a binding protein according to any one of claims. 1-20 and one or more pharmaceutically acceptable carriers. 22. Фармацевтическая композиция для лечения или предотвращения воспалительного заболевания, аутоиммунного заболевания, нейродегенеративного заболевания, рака, сепсиса, метаболического нарушения или повреждения спинного мозга, содержащая эффективное количество связывающего белка по любому из пп. 1-20.22. A pharmaceutical composition for the treatment or prevention of an inflammatory disease, autoimmune disease, neurodegenerative disease, cancer, sepsis, metabolic disorder or spinal cord injury, containing an effective amount of a binding protein according to any one of claims. 1-20. 23. Фармацевтическая композиция по п. 22, отличающаяся тем, что воспалительное заболевание, аутоиммунное заболевание или нейродегенеративное заболевание выбирают из группы, состоящей из астмы, ревматоидного артрита, системной красной волчанки (СКВ), множественного склероза, болезни Альцгеймера и болезни Паркинсона.23. The pharmaceutical composition of claim 22, wherein the inflammatory disease, autoimmune disease, or neurodegenerative disease is selected from the group consisting of asthma, rheumatoid arthritis, systemic lupus erythematosus (SLE), multiple sclerosis, Alzheimer's disease and Parkinson's disease. 24. Применение связывающего белка по любому из пп. 1-20 в изготовлении лекарственного средства для лечения или предотвращения воспалительного заболевания, аутоиммунного заболевания.24. The use of a binding protein according to any one of claims. 1-20 in the manufacture of a medicament for the treatment or prevention of an inflammatory disease, an autoimmune disease. 25. Применение по п. 24, отличающееся тем, что воспалительное заболевание, аутоиммунное заболевание или нейродегенеративное заболевание выбирают из группы, состоящей из астмы, ревматоидного артрита, СКВ, множественного склероза, болезни Альцгеймера и болезни Паркинсона.25. Use according to claim 24, wherein the inflammatory disease, autoimmune disease, or neurodegenerative disease is selected from the group consisting of asthma, rheumatoid arthritis, SLE, multiple sclerosis, Alzheimer's disease and Parkinson's disease. 26. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок содержит первую полипептидную цепь, содержащую аминокислотную последовательность в соответствии с SEQ ID NO: 87; вторую полипептидную цепь, содержащую аминокислотную последовательность в соответствии с SEQ ID NO: 89; и третью полипептидную цепь, содержащую последовательность в соответствии с SEQ ID NO: 91.26. Binding protein according to claim 1, wherein said binding protein comprises a first polypeptide chain comprising an amino acid sequence in accordance with SEQ ID NO: 87; a second polypeptide chain containing the amino acid sequence in accordance with SEQ ID NO: 89; and a third polypeptide chain containing the sequence in accordance with SEQ ID NO: 91. 27. Связывающий белок по п. 5, отличающийся тем, что указанный связывающий белок способен к связыванию ФНО человека и ИЛ-17 человека.27. The binding protein of claim 5, wherein said binding protein is capable of binding human TNF and human IL-17. 28. Связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок содержит первую полипептидную цепь, содержащую аминокислотную последовательность в соответствии с SEQ ID NO: 92; вторую полипептидную цепь, содержащую аминокислотную последовательность в соответствии с SEQ ID NO: 95; и третью полипептидную цепь, содержащую последовательность в соответствии с SEQ ID NO: 97.28. Binding protein according to claim 1, wherein said binding protein comprises a first polypeptide chain comprising the amino acid sequence in accordance with SEQ ID NO: 92; a second polypeptide chain containing the amino acid sequence in accordance with SEQ ID NO: 95; and a third polypeptide chain comprising the sequence according to SEQ ID NO: 97. 29. Связывающий белок по п. 9, отличающийся тем, что указанный связывающий белок способен к связыванию CTLA-4 человека и PD-1 человека.29. The binding protein of claim 9, wherein said binding protein is capable of binding human CTLA-4 and human PD-1. 30. Фармацевтическая композиция для лечения заболевания, выбранного из группы, состоящей из ревматоидного артрита, псориаза, остеопороза, инсульта, заболевания печени и рака ротовой полости, содержащая связывающий белок по п. 1, где указанный связывающий белок способен к связыванию ИЛ-17 и ИЛ-20.30. A pharmaceutical composition for treating a disease selected from the group consisting of rheumatoid arthritis, psoriasis, osteoporosis, stroke, liver disease and oral cancer, comprising a binding protein according to claim 1, wherein said binding protein is capable of binding IL-17 and IL -20. 31. Фармацевтическая композиция для лечения B-клеточного рака, содержащая связывающий белок по п. 1, отличающийся тем, что указанный связывающий белок способен к связыванию CD3 и CD20.31. A pharmaceutical composition for the treatment of B cell cancer, comprising a binding protein according to claim 1, wherein said binding protein is capable of binding CD3 and CD20. 32. Фармацевтическая композиция по п. 31, отличающаяся тем, что B-клеточный рак выбран из группы, состоящей из лимфомы Ходжкина, неходжкинской лимфомы (НХЛ), лимфобластного лейкоза/лимфомы из В-клеток-предшественников, опухолей из зрелых В-клеток, B-клеточного хронического лимфоцитарного лейкоза/мелкоклеточной лимфоцитарной лимфомы, B-клеточного пролимфоцитарного лейкоза, лимфоплазмоцитарной лимфомы, мантийноклеточной лимфомы, фолликулярной лимфомы, кожной лимфомы из клеток фолликулярного центра, В-клеточной лимфомы маргинальной зоны, волосатоклеточного лейкоза, диффузной В-крупноклеточной лимфомы, лимфомы Беркита, плазмацитомы, плазмоклеточной миеломы, посттрансплантационного лимфопролиферативного расстройства, макроглобулинемии Вальденстрема и анапластической крупноклеточной лимфомы.32. A pharmaceutical composition according to claim 31, characterized in that the B-cell cancer is selected from the group consisting of Hodgkin's lymphoma, non-Hodgkin's lymphoma (NHL), lymphoblastic leukemia / lymphoma from B-progenitor cells, tumors from mature B-cells, B-cell chronic lymphocytic leukemia / small cell lymphocytic lymphoma, B-cell prolymphocytic leukemia, lymphoplasmacytic lymphoma, mantle cell lymphoma, follicular lymphoma, cutaneous lymphoma from cells of the follicular center, B-cell lymphoma of the marginal zone, hairy cell lymphoma Burkit, plasmacytoma, plasma cell myeloma, post-transplant lymphoproliferative disorder, Waldenstrom's macroglobulinemia, and anaplastic large cell lymphoma. 33. Фармацевтическая композиция для лечения аутоиммунного или воспалительного заболевания, содержащая связывающий белок по п. 1, где указанный связывающий белок способен к связыванию ФНО и ИЛ-17.33. A pharmaceutical composition for the treatment of an autoimmune or inflammatory disease, comprising a binding protein according to claim 1, wherein said binding protein is capable of binding TNF and IL-17. 34. Фармацевтическая композиция по п. 33, отличающаяся тем, что аутоиммунное заболевание выбрано из группы, состоящей из болезни Крона, псориаза (включая бляшечный псориаз), артрита (включая ревматоидный артрит, псориатический артрит, остеоартрит или идиопатический артрит), множественного склероза, анкилозирующего спондилита, деформирующей артропатии, системной красной волчанки, увеита, сепсиса, нейродегенеративных заболеваний, регенерации нейронов, повреждения спинного мозга, первичных и метастатических раковых заболеваний, респираторного нарушения - астмы, аллергической и неаллергической астмы, астмы, вызванной инфекцией, астмы, вызванной инфекцией респираторно-синцитиальным вирусом (РСВ), хронического обструктивного заболевания легких (ХОЗЛ), заболевания, характеризующегося воспалением дыхательных путей, эозинофилии, фиброза и избыточной выработки слизи, кистозного фиброза, фиброза легких, атопического заболевания, атопического дерматита, крапивницы, экземы, аллергического ринита, аллергического гастроэнтерита, воспалительного и/или аутоиммунного заболевания кожи, воспалительного и/или аутоиммунного заболевания органов желудочно-кишечного тракта, воспалительных заболеваний кишечника (ВЗК), язвенного колита, воспалительного и/или аутоиммунного заболевания печени, цирроза печени, фиброза печени, фиброза печени, вызванного вирусом гепатита B и/или C, склеродермы, опухолей или злокачественных новообразований, гепатоклеточной карциномы, глиобластомы, лимфомы, лимфомы Ходжкина, вирусной инфекции, бактериальной инфекции, паразитарной инфекции, инфекции HTLV-1, подавления защитных иммунных реакций типа 1 и подавления проявления защитной иммунной реакции типа 1 на протяжении вакцинации.34. A pharmaceutical composition according to claim 33, wherein the autoimmune disease is selected from the group consisting of Crohn's disease, psoriasis (including plaque psoriasis), arthritis (including rheumatoid arthritis, psoriatic arthritis, osteoarthritis or idiopathic arthritis), multiple sclerosis, ankylosing spondylitis, deforming arthropathy, systemic lupus erythematosus, uveitis, sepsis, neurodegenerative diseases, neuronal regeneration, spinal cord injury, primary and metastatic cancers, respiratory disorders - asthma, allergic and non-allergic asthma, asthma caused by infection, asthma caused by respiratory infection syncytial virus (RSV), chronic obstructive pulmonary disease (COPD), a disease characterized by airway inflammation, eosinophilia, fibrosis and excess mucus production, cystic fibrosis, pulmonary fibrosis, atopic disease, atopic dermatitis, urticaria, eczema, allergic rhinitis, and allergic gastroenteritis, inflammatory and / or autoimmune skin disease, inflammatory and / or autoimmune disease of the gastrointestinal tract, inflammatory bowel disease (IBD), ulcerative colitis, inflammatory and / or autoimmune liver disease, liver cirrhosis, liver fibrosis, liver fibrosis, caused by hepatitis B and / or C virus, scleroderma, tumors or malignant neoplasms, hepatocellular carcinoma, glioblastoma, lymphoma, Hodgkin's lymphoma, viral infection, bacterial infection, parasitic infection, HTLV-1 infection, suppression of protective immune responses of type 1 and suppression of the manifestation of protective type 1 immune response during vaccination. 35. Фармацевтическая композиция по п. 34, отличающаяся тем, что аутоиммунное заболевание представляет собой ревматоидный артрит, системную красную волчанку или множественный склероз.35. A pharmaceutical composition according to claim 34, wherein the autoimmune disease is rheumatoid arthritis, systemic lupus erythematosus, or multiple sclerosis. 36. Фармацевтическая композиция для лечения рака, содержащая связывающий белок по п. 1, где указанный связывающий белок способен к связыванию CTLA-4 и PD-1.36. A pharmaceutical composition for treating cancer, comprising a binding protein according to claim 1, wherein said binding protein is capable of binding CTLA-4 and PD-1. 37. Фармацевтическая композиция по п. 36, отличающийся тем, что рак представляет собой меланому, рак почек, рак предстательной железы, аденокарциному поджелудочной железы, рак молочной железы, рак толстой кишки, рак легких, рак пищевода, плоскоклеточную карциному головы и шеи, рак печени, рак яичников, рак шейки матки, рак щитовидной железы, глиобластому, глиому, лейкоз, лимфому или другие злокачественные новообразования.37. A pharmaceutical composition according to claim 36, characterized in that the cancer is melanoma, renal cancer, prostate cancer, pancreatic adenocarcinoma, breast cancer, colon cancer, lung cancer, esophageal cancer, squamous cell carcinoma of the head and neck, cancer liver, ovarian cancer, cervical cancer, thyroid cancer, glioblastoma, glioma, leukemia, lymphoma, or other malignant neoplasms.
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